Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-11.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Sep 2024 – 11 Sep 2024 | Medical Devices & Rad Health | Clean | |
| 30 Oct 2018 – 1 Nov 2018 | Medical Devices & Rad Health | Clean | |
| 16 Nov 2016 – 18 Nov 2016 | Medical Devices & Rad Health | 483 | On file |
| 27 Oct 2014 – 29 Oct 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Dec 2011 | Not recorded | 483 | View 483 → |
| 11 Aug 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Oct 2014
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Nicholas C Mendiola
Investigators
FDA investigators tied to this site in the record.
Nicholas C Mendiola5 insp.
Wendy M Stone1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Intersurgical Inc's 4 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat